Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status

Recruiting Phase 3 Interventional Study
Anemia, Iron Deficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
15 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
3,200 (estimated)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Other
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About This Trial
The World Health Organization (WHO) currently recommends the pregnant women receive iron-containing supplements and, in settings where calcium intake is low, calcium supplements. Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption. The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Burkina Faso: married or unmarried pregnant women aged ≥15 years * Pakistan: married pregnant women ≥18 years * Willing to receive all antenatal care at a study clinic * Willing to stop iron folic acid supplementation to receive the study intervention * Hb ≥70 g/L * 6\<20 week…
Contacts

Amanda C Palmer, PhD

1 (410) 955-2061

acpalmer@jhu.edu

CONTACT

Monica Pasqualino, PhD

mpasqua2@jhmi.edu

CONTACT